Analogue fluid flow programming structures

ABSTRACT

A semi-automatic device for peroforming complex fluid processing procedures adapted to hemodialysis. The structure includes a disposable component formed by layers of transparent, flexible plastic sheets, sealed to each other according to a predetermined pattern defining between each pair flow paths and pockets which respectively form fluid passages and reservoirs. The structure also includes a permanent installation which is to receive the disposable component in order to form therewith a complete apparatus for automatically processing fluids, such as treating or determining the characteristics of a fluid such as human blood, according to predetermined sequences which may be controlled by internal and/or external information processing devices.

[ Nov. 27, 1973 ANALOGUE FLUID FLOW PROGRAMMING Primary ExaminerFrank A.Spear, Jr.

STRUCTURES Attorney-Blum, Moscovitz, Friedman & Kaplan ABSTRACT [76]Inventor: Eric S. Lichtenstein, 24 E. 93rd St.,

New York, NY. 10028 A semi-automatic device for peroforming complexfluid processing procedures adapted to hemodialysis. The structureincludes a disposable component formed by layers of transparent,flexible plastic sheets, sealed to each other according to apredetermined pattern defining between each pair flow paths and pocketswhich respectively form fluid passages and reservoirs. The structurealso includes a permanent installation which is to receive thedisposable component in order to form therewith a complete apparatus forautomatically processing fluids, such as treating or [56] ReferencesCited UNITED STATES PATENTS %e m hme c wwle am u N mn .la am fe o m e dt.wmms .mpym am t e a ed mmw h um Cwnfi 00 mi 21 .mmwm

m e am m dhwi X XXW 1 11 2 22 3 33 //2 0 00. l 11 2 22 Wu L m k a m mimam e .1 FUHKW 20 88 77766 99999 11111 Ill/l 29620 11 82246 87362 0776622 0 ,R 33 33 17 Claims, 3 Drawing Figures 7; 5 ATTO R NEYS ll ANALOGUEFLU FLOW PROGMMING STRUCTURES BACKGROUND OF THE INVENTION The presentinvention relates to fluid processing structures.

In particular, the present invention relates to structures used fortesting or treating fluids as by determining predeterminedcharacteristics of the fluids or by changing the characteristics of mefluids. In the case of human blood, for example, various tests may becarried out in order to determine the characteristics of the blood,and/or certain treatment maybe made in order to change thecharacteristics of the blood.

At the present time systems of this type require the services of highlyskilled personnel such as physicians nurses, and technicians of manydifferent types. The processes involved are fairly complex. It may benecessary to carry out many different procedures on a fluid such ashuman blood during complex treatments such as hemodialysis.Accomplighing this with conventional processes this becomes extremelyexpensive and time consuming. This cost, further aggravated by theunavailability of skilled personnel even when funds are available, oftenmakes therapy unavailable to patients requiring it for maintenance oftheir lives or well being. The equipment required for the above purposesis exceedingly delicate and expensive. A considerable amount of trainingis required for proper operation of such equipment and for properevaluation of various tests of its effectiveness. This device, embodiedexemplifying almost complete integration of the procedures ofhemodialysis into an automatic system, is suitable for mass-productionand distribution. Similarly designed systems could apply to automatedmonitoring and therapy of shock, or diabetic keto-acidosis, and othersituations frequently encountered is specialized, hospital intensivecare units. They would significantly improve care in these situations byaltering the balance of personnel time between performance of requiredprocedures and decision-making based upon repeated evaluation of theresults of therapy. Pertinent information could be made rapidly andcontinuously available. Anticipated therapeutic alternatives could berapidly instituted. Automated medical systems could also extendemergency capabilities, for example, providing therapy for cardiacarrest with rapidly available cardiopulmonary bypass. With presentmethods the costs of these diagnostic and therapeutic possibilities areprohibitive.

SUMMARY OF THE INVENTION It is accordingly a primary object of thepresent invention to provide fluid processing structures which willavoid the above drawbacks, to improve the efficiency of existing medicalfacilities, and'provide extension of servies to additional patients atreduced cost.

In particular, it is an object of the present invention to provide afluid processing structure which can be automated and computerized tothe extent that all the desired test and other operations of aparticular procedure can be carried out by an extremely small number ofoperators who need not be particularly skilled.

Another object of the present invention is to provide, for systems ofthis type, a permanent installation which includes the relativelyexpensive controls, and a disposable component, containing the activeprinciples of the procedure in a spatially ordered configuration whichcan be manufactured at an extremely low cost, to be used in conjunctionwith the permanent installation in order to carry out the required fluidprocessing operations.

Another object of the disposable component is to anticipate the logicalrelationships of, and provide the fluid flows required for performingthe desired procedures, including sequences of flows, proportioning ofpredetermined mixtures, and other such necessary functions, within thepatterns of flow paths and reservoirs formed by seals between adjacentlayers of plastic sheets.

Also, it is an object of the invention to provide a disposable componentwith sterile packaging, where necessary, and sealed functionalconstruction, whereever possible.

The unit is keyed to interact in the prescribed manner with the externalhardward, the operative components consisting of various non-invasivevalue and pump mechanisms.

' This construction reduces preparation time and complexity. Itanticipates the steps in preparation for a procedure in the integrateddesign and automated sequences of function.

Also, it is an object of the invention to improve safety of theprocedures especially when directly involving patients therapy.Standardization of design and functions will prevent accidents ofomission, minimizing possible patient errors, and with appropriatemonitoring, control for intrinsic malfunctions. The sealed construction,and materials used, will provide insulation against electrical hazards.

A further object of the invention is to include in the disposablecomponent as many functional control systems as can be compatible withlow cost, affording a reduction to a minimum the size, expense andcomplexity of the permanent installation required.

In particular,.it is an object of the invention to provide a disposablecomponent which can be used with a permanent installation in such a waythat relatively complex tests and other treatment or processing can becarried out in a purely automatic manner giving readings and the likewhich can be used with logic systems of computers in order to determine,with a high degree of accuracy and at relatively low cost, theinformation required in connection with the fluid which is processed.

According to the invention the structure includes a permanentinstallation and a disposable component to be used therewith. Thepermanent installation includes a wall having a front face formed with apredetermined pattern of grooves, recesses, and when necessary inlet andoutlet connections. An access door is located adjacent the front face ofthe wall to hold a disposable component between these rigid structures.The disposable component includes at least a pair of transparent,flexible plastic sheets which are sealed to each other according to apredetermined pattern which will define between the sheets predeterminedfluid passages and pockets providing predetermined flow paths andreservoirs, respectively, for the fluid which is to be processed, andcontaining the constituents of the procedure that will be consumed,contaminated or otherwise rendered ineffective for repeated use. Thesepassages and reservoirs will register with the grooves and recesses ofthe wall of the permanent installation. This latter installation willhave controls in the form of valves, photocells, pumping units,electrical contacts, and the like, coacting with the transparent sheetsin order to control the flow of the fluids, perform designated tests, aswell as provide predetermined treatment thereof. There may be inlets andoutlets, where necessary, to perform transportations of aliquots offluid automatically removed from the disposable components fluid flowflow programming, or to inject functionally active fluids in any of thepreprogrammed layers of the disposable component.

BRIEF DESCRIPTION OF DRAWINGS The invention is illustrated, by way ofexample, in the accompanying drawings, which form part of thisapplication and in which:

FIG. 1 is a schematic front elevation illustrating the manner in whichthe invention is applied to a hemodialysis system;

FIG. 2 is a front elevation of the wall of the permanent installation,FIG. 2 also schematically illustrating the control unit andfragmentarily showing access door in an open position; and

FIG. 3 is a fragmentary sectional plan view, taken along line 3-3 ofFIG. 1, in the direction of the arrows, and showing in section, part ofthe walls of the permanent installation and part of the disposablecomponent situated therebetween, FIG. 3 also showing one type ofinterface with various valves and pressure-sensing devices, as well aspart of a pumping means.

DESCRIPTION OF PREFERRED EMBODIMENTS In the drawings, the invention isshown as applied to a hemodialysis system, but it is to be understoodthat the principles of the invention are of general applicability to alltypes of systems where relatively complex manipulations of fluids arerequired.

Referring to FIG. 1, there is schematically represented therein ahemodialysis system which includes a permanent installation 12 and adisposable component 14.

The permanent installation 12 of the system 10 includes a pair oflateral stands 16 which serve to carry the entire system on a balanceapparatus (not shown) and functionally contained in the permanentinstallation 12. To the left of rear control wall 18 (FIG. 3) theinstallation 12 includes a control unit 20. This control unit hasvarious operating buttons 22 and 24 whichcan be used to transmitsuitable electrical signals for selecting a predetermined operation. Theentire system is connected to a suitable source of electrical energythrough the cord 25 which has the grounded plug 26 which can be insertedinto any suitable wall outlet. The assembly also includes devices fortransmitting signals to a computer so that the various items ofinformation can be automatically obtained and processed. If desired thecomputer structure may itself be housed within and form part of the unit20.

As may be seen from FIG. 3, the rear control wall 18 is formed at itsfront surface, which is visible in FIG. 2, with various recesses 28 andgrooves 30 defining a predetermined pattern of the recesses and groovesfor a purpose referred to below. Also, the rear wall 18 carries at apair of the recesses 28 suitable pumping devices 32 communicating withthe interior of the recesses and acting to pump fluids in a mannerdescribed in greater detail below. The illustrated structure alsoincludes various control and detecting devices such as the schematicallyrepresented valves 34 and photocells of conductivity detectors 36.

At its right end the rear wall 18 is connected by a hinge 38 with thefront wall 40 which is transparent, preferably being made of anysuitable clear plastic, with a pattern of grooves and recessescorresponding to those of the control wall. At its end which is distantfrom the hinge 38 the front wall 40 carries a suitable latch orreleasable lock device capable of coacting with a catch 42 forreleasably holding the transparent front wall 40 in its closed positionadjacent the front surface of the rear wall 18 which is visible in FIG.2. When the front wall 40 is in its closed position it serves to retainbetween the wall 40 and the wall 18 a disposable component 14.

The rear wall 18 also carries a pair of vertical bars 44 respectivelyterminating at their top ends in eyes 46.

The disposable component 14 is made up of layers of transparent flexiblesheets which are sealed to each other according to a predeterminedpattern. For example in the hemodialysis system to be described, a pairof these sheets 62 may be made of a clear plastic such as polyethylene,although other suitable plastics may be used. The pattern according towhich these sheets are sealed to each other will create fluid passages48 and pockets 50 which define flow paths and reservoirs, within thedisposable component for the fluid which is to be processed and tocontain necessary reagents or active principles of the process orprocedure.

A mounting means is provided for mounting the disposable component 14 onthe permanent installation. This mounting means in the illustratedexample takes the form of a rod 52 which extends through an openendedtube 54 which is defined along the top edge of the component 14 by thesealing of the sheets thereof to each other. Thus with the rod 52extending through the tube 54 the entire disposable component 14 can bemounted on the permanent installation 12 simply by placing the ends ofthe rod 52 in the eyes 46.

The pattern of sealing of the plastic sheets to each other to form thedisposable component 14 is such that the component 14 will have fluidpassages and pockets which register with the grooves and recessesvisible in FIG. 2. In addition it is to be noted that the area of sheetswhich form the disposable component 14 is substantially greater than thearea of the front surface of the rear wall 18 so that these sheets ofthe component 14 extend a considerable distance above and below thewalls of the permanent installation 12. At these areas above and belowthe walls, the disposable component 14 has additional pockets andpassages as well as connections for fluid-supply and discharge lines, asreferred to in greater detail below.

Referring to FIG. 2, it will be seen that the rear control wall 18carries at its rear surface a housing 56 in which are housed variousactuating and sensing units with suitable interfaces or connectionsincorporated in the structure of the control wall 18. For example thephotocell units 36 actuated by the light which passes from a source inthe control wall, through the disposable component 14, to be reflectedby mirrored surfaces on the inside of the door to activate a photodetector on the control wall. These are connected in electrical circuitsenabling the photocell units 36 to detect significant air or fluidlevels in the fluid flowing within the pathways of the disposablecomponent. The housing 56 also contains suitable solenoids, or motorscapable of displacing armatures 58 which form valve plungers. As isapparent from FIG. 3 the disposable component 14 is composed oftransparent plastic sheets se and 62 which are sealed to each other attheir interface 64 so as to define between themselves the passages suchas the passage 66 indicated in FIG. 3. The sheets which form thedisposable component I4 also may be provided with openings through whichlocating pins 68 pass for providing a precise positioning of thedisposable component on the permanent installation. It is furthermore tobe noted that the front wall 40 is provided at its rear surface withrecesses and grooves matching those at the front surface of the rearwall so that the disposable component I4 is precisely positioned betweenthe walls of the permanent installation in the manner illustrated inFIG. 3. The various solenoid motors, or the like housed within thehousing 56 are designed to be actuated in appropriate sequences by theelectrical circuits activated by the operating buttons 22 and 24, withthe result that a plunger such as the plunger 58 of FIG. 3 can beadvanced to the position shown in FIG. 3 for closing a fluid passage.When this plunger 58 is retracted then the passage will be opened. Inthis way suitable valve controls are provided for determining thepathway and timing of the fluid flows. A second plunger 6% is shown inits retracted position maintaining the passage 66 open. Additionalactive surfaces along the functional grooves of the control wall 18,such as the plunger 70 shown in FIG. 3 may through suitable transducersdetect pressure changes in the fluids within flow paths or reservoirs,to provide information for automatic operation. Furthermore, it ispossible to incorporate elements, such as thermocouples, responsive totemperature changes, and contact points with conductive properties forelectrical measurements. Appropriate interface manifolds incorporated inthe disposable component will allow spectrophotometric measurements tobe obtained, or access to the internal flow passage for inlet or outletof fluids.

At other points along the grooves channels in the control wall I8pumping means are incorporated, as designated by 32 in FIG. 2, shown incross section in FIG. 3. This pumping can be provided by any suitablemeans for creating localized pressure differentials, as for exampleendless chains 72 driven from any suitable motor and supported bysuitable sprockets 74 so that pumping rollers "76 will be advanced oneafter the other across the length of a pocket defined between thesheets, such as the pocket 86 which is fragmentarily illustrated in FIG.3. The result is that each pumping roller 76 will push a quantity offluid ahead and suck a quantity of fluid behind itself, thus bringingabout a pumping action according to which fluid will be pumped from theleft toward the right, as viewed in FIG. 3, with respect to the pocketor reservoir 8th, in accordance with the desired flow characteristics ofthe particular circuit involved. Or this pumping means may be providedby external fluid pumping to provide alternately increasing ordecreasing pressures of fluid contained in a pumping pocket, sealedexcept for inletoutlet connections, in layers of plastic sheets outsidethe layers providing the primary passages and reservoirs, in a multiplelayer configuration. Confined within the recesses of the control walland door, introductions of fluid under pressure into these pumping meanswill transmit this pressure to the inner fluid volume, forcing it toexit via the passages open to it. These exit passages can be similarlycontrolled by higher pressure, nonparallel intersecting fluid flowcircuits forming valves, to provide unidirectional flow. Theintroduction of proportional resistances in such pressure regulates flowpaths can, in addition to reservoir and passage dimensions, providevolumetric controls.

Considering now the specific hemodialysis system which is shown in thedrawings, the sheets which form the disposable component 14 definebetween themselves a pair of passages I2 and I terminating at their leftends, as viewed in FIG. I, in connections I06 and I08, respectively,adapted to be connected with suitable liquid-supply lines. Thus, at thispart the sheets may have suitable rigid plastic connecting valves forexample, inserted into the open ends of the passages I02 and MM sealedto the sheets so as to form a fluid-tight connection. Flexible tubes maybe attached to the valve connectors I06 and 10% so that sources of watercan be connected with the passages M92 and I04. These sources of watermay be distilled or tap water, for example, or from hot and coldsources. It will be noted from FIG. 2 that the lower portions of thepassages I02 and I04 register with grooves III and I12, respectively,provided with valves I114 and I16 so that in this way the source ortemperature of liquid can be regulated. The supplied liquid will flowalong the passage M8, part of which registers with the groove 120 intothe water purification reservoir I22 formed by one of the pockets S0defined between the sheets. This reservoir 122 communicates through thepassage I24, which registers with the groove 1126 into a reservoir 128which forms a water reservoir and which registers with the recess I30,at the lower portion of the reservoir I28. At this part of the apparatusthere is one of the photocell conductivity detectors 1% to transmit asignal givinginformation with respect to the level or quantity water inthe reservoir I2$. The water purification carried out in the reservoirI22 will be performed by enclosing within the reservoir I22 before thesheets are sealed to each other a device containing filters and suitablechemicals adapted to the particular nature of the water supplied so asto sterilize and deionize the water, and provided with characteristicssuitable for the purpose intended. The reservoir I28 communicatesthrough a passage I32 with a reservoir I34 registering with one of therecesses 28 and adapted to contain a saline concentrate. The admissionof the saline concentrate, contained in poclred I34 FIG. I to the waterfrom reservoir I28 is controlled by coaction of a value I36 and theinternal structure of the disposable components proportioningresistances to create uniform mixtures, as will be described below.

Through this value the reservoir I28 will communicate with a passageMilli leading to a saline reservoir I42 situated above the walls of thepermanent installation and communicating with an air trap 144 which inturn communicates through a passage 1% with an air pressure monitorpocket I413 registering with the recess 15th. An active surface such asthe plunger shown in FIG. 3 will sense the pressure contained within thesystem reservoir Me at the recess use. It will be noted that part of thepassage we registers with the groove I52.

The reservoir I26, at its location above the permanent installationcommunicates through a suitable passage with a second air trap I54ldefined between the sheets of the disposable component I4 andcommunicating through the passage 156, also defined between the sealedsheets, with the air pressure monitor pocket 148. Through thecombination of these air traps, photocell-conductivity fluid leveldetectors 36, and fluid pressure sensitive devices in the control wallrecesses, adequate levels of liquid can be maintained to supply thefunctional requirements of the various circuits, while avoiding thedanger of introducing air bubbles into the fluid circulations.

From the passage 132 purified water flows under hydrostatic pressureinto passage 140 and reservoir 142, and by gravity into a passage 158registering with the groove 160. Valves 136 and 164 control the deliveryof the purified water to either saline 140, or dialysate 158, circuits.Valve 164 coacts with the internal resistance adjustment andpredetermined volume of the disposable component to proportion themixture of purified water from reservoir 128 and dialysate concentratefrom reservoir 166, under controlled pressure within recess 168, to formdialysate.

Passage 158 then communicates through the three passages 170, 172, 174,with the dialysate reservoirs 176 and 178. These passages 170, 172, and174, respectively register with the grooves 180, 182, and 184, which arecontrolled by the valves 186, 188, and 190, so that in this way thecontrol of the flow through the various passages 170, 172, and 174 canbe regulated to determine the flow of the dialysate, as it is formed,alternately into the dialysate reservoirs 176 and 178.

It will be noted that through the passages 172 and 174 the flow can becontrolled to-the reservoirs 176 and 178 while through the passage 170it is possible to provide for direct flow of the liquid in thiscirculation to a waste reservoir 192 in the form of a pocket definedbetween the sheets of the disposable component 14. This waste reservoir192 has at its left end, as viewed in FIG. 1, a value 194 through whichthe contents may be drained.

From the dialysate reservoirs 176 and 178 the liquid can flow throughthe passages 192 and 194 into a common passage 196 leading into adialyzer 198. It will be noted that the dialyzer 198 can be a standarddevice contained between the sheets of disposable component 14 beneaththe wall of the permanent installation. The passages 192 and 194respectively register with the grooves 200 and 202. These grooves arerespectively provided with control valves 204 and 206. The recesses 208and 210 respectively register in part with the dialysate reservoirs 176and 178 and they are provided with heating element surfaces 212 and 214as well as photocell-conductivity detectors 36 and thermocouples capableof detecting the nature and level of the dialysate in the reservoirs 176and 178. In accordance with the characteristics detected in this way andthe programming of the permanent installations to alternately fill andempty dialysate reservoirs one or the other of the valves 204 and 206will be opened to admit the dialysate into the dialyzer 198. In thedialyzer the blood from the patient will be treated in a standard mannerby dialysis and ultrafiltration across a suitable membrane. Such amembrane is incorporated into the dialyzer 198. The dialysate will bepumped by the upper pump means 32 at the pumping pocket 216 received inthe pumping recess 28, so that this liquid will be pumped through thepassage 158 back into the empty dialysate reservoir 176 or 178 thusachieving recirculation if desired, or to waste. Between the dialyzer198 and the pump reservoir 216 is a passage 220 which communicatesthrough a pocket 222 with the pump reservoir 216. At this pocket 222 isthe recess 224 of the rear wall 18, and at this recess is located asuitable standard hemoglobin detector carried by the rear housing 56.

A dialysate purification reservior 226 is defined between the sheets ofthe disposable component 14 and registers with the recess 228 shown inFIG. 2. The rear wall carries at the connection between the recess 228and the recess 224 the valves 230 and 232 so that in this way the flowfrom the dialysate purification pocket along the recirculating passage234 can be regulated. This passage 234 registers with the groove 236shown in FIG. 2, and it will be noted that an additional valve 238 isprovided to control the flow through the passage 234.

Thus, through control of the operation of the valves 232 and 238, withsuitable settings of the operating buttons at the control panel 20, itis possible to circulate the dialysate through the dialysatepurification reservoir 226, containing suitable exchange and bindingresins, chemicals and reagents to regenerate used dialysate. Thesecomponents of the procedure, as well as all the others such as salineand dialysate concentrates, and the reagents necessary for appropriatechemical anaylsis within the sealed analyzer unit 276, are situated atlocations destined to form pockets or reservoirs according to thepredesigned patterns and flows and fluid manipulations necessary toperform the selected procedure, preliminary to sealing the flexibleplastic sheets to each other to form the disposable component.

All of the above detailed description in connection with the specificexample of a hemodialysis system relates to the features which are usedin connection with obtaining and circulating of dialysate. It is ofcourse also required to provide an extracorporeal circuit and suitablesafety monitoring, for the blood of the patient so that the blood canpass through the dialyzer for treatment, and then be returned to thepatient. For this purpose the sheets which form the component 14 areheated sealed to define a passage 240 formed with an inlet connection toreceive the flexible line 242 which is connected in standard ways withthe blood system of the patient in the manner shown schematically inFIG. 1. In this way blood from the patient will enter into thehemodialysis system. The lower pump means 32 which has the pumpingrollers 76 moving horizontally from the left toward the right, as viewedin FIGS. 2 and 3, communicates with the passage 240 through a passage243 defined between the sheets due to the sealing thereof. Thesepassages 240 and 242 respectively register with the vertical andhorizontal grooves 244 and 246 formed in front surface of the rear wall18, as shown in FIG. 2.

The saline reservoir 142 communicates with the passage 243 to allowsaline priming of the extracorporeal circuit, through a verticallyextending passage 248 which registers with the vertical groove 250fonned in the front surface of the rear wall 18. Thus, the blood will bepumped into the passage 252 formed between the sheets of disposablecomponent 14, and in this way the blood will reach the dialyzer 198.This passage 252 which receives the blood registers in part with agroove 254 provided with an enlarged recess portion 256 where a bloodpump pressure monitor is mounted within the housing 56 so as to detectthe pressure of the blood pumped by the lower pump means 32.

The pumped blood will thus flow through the dialyzer 198 incountercurrent to the dialysate, with the processing taking placethrough a suitable membrane within the dialyzer 198, as is well known,and then the blood will reach the dialyzer outlet passage 258 definedbetween the sheets of disposable component 14 through the sealingpattern. This passage 258 communicates with a reservoir 260 formed by apocket defined between the sealed sheets, and this reservoir willregister with the recess 262 formed in the front surface of the rearwall 18. The upper part of the passage 258 will register with the groove264. The reservoir 260 forms on the one hand a bubble trap and on theother hand a blood return line monitor. For this purpose there are apair of photocells and electrical conductivity detectors 26b and 268carried by the rear housing 56 and communicating with the interior ofthe recess 262 so that the level of the blood returning to the patientin the reservoir 26th can be detected, thus preventing air embolism fromoccurring. The pressure of returning blood is monitored by detector 300.From the blood monitoring reservoir 264) the blood returns to thepatient through a passage 270 defined between the sheets of thecomponent 14 and placed in communication with a flexible line 272 whichagain is connected with the patient, as shown schematically in H6. 1.

However, part of the blood may be delivered through a passage 274 into ablood analyzer 276 defined between the sheets. The passage 274 registerswith a groove 278 in the front surface of the rear wall 18, and at thispoint there is a valve 280 which can be controlled from the panel 2@ soas to regulate the flow of blood into the analyzer portion of thedisposable component 2'76 which registers with the recess 282 formed inthe front surface of the rear wall 18.

The analyzer component contains fluid passages and reservoirs, as wellas pockets for reagents, and structures suitable to perform themanipulations necessary for chemical analysis of significantcharacteristics of the dialyzed blood. These operations of flow, mixing,proportioning, filtration, dialysis and so forth, are performed in amanner similar to the procedures of hemodialysis, but on a smallerscale, and can be adapted, as well, to function independently from suchlarge units as the hemodialysis system, as a means of automatinglaboratory testing.

The passage 244) communicates also with a reservoir 284 which containssuitable anticoagulant material to be fed to the passage 242 in order toflow with the blood so as to prevent coagulation thereof. For example asuitable stabilized heparin composition may be initially located withinthe pocket 284 and controlled by a unit in the housing 56 so as to feedto the blood flowing the dialyzer a sufficient amount of anticoagulantin order to keep the blood flowing freely at all times through theapparatus.

It is thus possible with the above structures of the invention to carryout hemodialysis in a fully automatic manner, achieving through computerinformation processing techniques a considerable amount of precisecontrol in a manner which heretofore required the operations of skilledpersonnel and expensive equipment. All of the relatively expensivecomponents form part of the permanent installation 12 while thedisposable component 14 is quite inexpensive to manufacture.

The sheets are heat sealed to each other to define the predeterminedreservoirs and flow paths and to contain in certain pockets suitablereagents, and this inexpensive disposable component 14 can readily bemounted on the permanent installation in a manner described above. Theoperator need only connect the connections 11% and 1108 to suitablesources of water, and after the saline and dialysate have been providedin a suitable manner between the sheets of component 14 the lines 242and 272 are connected with the patient and the hemodialysis can thenproceed. After the operations are completed all of the lines aredisconnected and the component 14 may be removed to replace by anothercomponent to be used with the next patient. The removed component 14 maybe preserved or it may be discarded. With this system of the inventionit is possible for unskilled and relatively untrained individuals to begiven simple instructions for initiating the sequential operationsnecessary to perform a complex procedure such as hemodialysis. These maybe reinforced by the intemal programming of the unit, and by indicatorlights associated with the control buttons 22 and 24. The mounting ofthe component 14 on the permanent installation becomes fairly automatic,and the same is true of the connection of the water and blood lines.Therefore, this system accomplishes its prime objective, the speedingand simplification of procedures necessarily performed by human actionsin providing complex medical diagnostic or therapeutic techniques. Theinvention shown utilizing this system, is extremely well suited forhemodialysis treatments to be performed by patients at home, adevelopment that has been found necessary if all patients requiring thisform of treatment are to have it made available.

What is claimed is:

1. For use in the processing of fluids, at least a pair of flexibleplastic sheets sealed to each other according to a predetermined patterndefining between said sheets fluid passages and pockets situatedinwardly of and spaced from the peripheries of said sheets and formingpredetermined flow paths and reservoirs, respectively, for the fluidwhich is to be processed and for containing necessary active principlesof the processing, said sheets having inlet and discharge connectingportions to be connected with fluid supply and discharge lines,respectively.

2. The combination of claim 1 and wherein the pattern of sealing of saidsheets to each other defines also valve and pumping mechanisms adaptedfor pumping fluid along said passages and into and out of saidreservoirs.

3. The combination of claim 1 and wherein said sheets are transparent sothat fluid between the sheets is visible and can have characteristicsthereof detected by light-signal systems.

4. The combination of claim l and wherein said sheets include a mountingportion for adapting the sheets to be mounted on an apparatus whichcoacts with the sheets.

5. In an apparatus for processing fluids, a permanent installation and adisposable component to be used therewith, said permanent installationincluding a control wall having a front surface formed with recesses andgrooves according to a predetermined pattern and an access wall withsimilar recesses and grooves located adjacent said front surface of saidcontrol wall for holding a disposable component in engagement with saidfront surface of said control wall, said disposable component includingflexible plastic sheets sealed to each other according to a patternproviding passages and pockets which are situated inwardly of and spacedfrom the peripheries of said plastic sheets and which respectivelyregister with said grooves and recesses, said passages and pocketsproviding predetermined flow paths and reservoirs, respectively, forfluid to be processed, and for containing necessary active principles,and said permanent installation including at said control wall thereofcontrol means communicating with or coacting with said passages andrecesses for controlling the flow of fluid in the passages and pocketsof the disposable component.

6. The combination of claim and wherein the control means carried bysaid control wall includes valve plungers for pressing the sheets ofsaid disposable component together at the passage defined therebetweenand for releasing the sheets from each other at the passages so as toclose and open, respectively, predetermined fluid passages definedbetween the sheets.

7. The combination of claim 5 and wherein said sheets are transparent,and said control means including light-responsive devices responding tothe passage of light through said sheets for receiving signalsindicative of the characteristics of the fluids, said front wall beingtransparent so that light can pass through the sheets to providevisibility of the ongoing processes.

8. The combination of claim 5 and wherein said sheets of said disposableunit include inlet and outlet connections.

9. The combination of claim 5 and wherein a mount ing means forms partof said permanent installation and coacts with said disposable componentfor mounting the latter removably on the permanent installation.

10. The combination of claim 5 and wherein said disposable componentincludes sheets, the area of which is greater than that of said rearwall, said sheets having portions extending beyond said walls of saidpermanent installation and defining additional pockets and passages forthe processed fluid.

1 l. The combination of claim 5 and wherein said permanent installationand disposable component form a hemodialysis and analytic monitoringsystem, said pockets and passages forming a flow path for blood and aflow path for dialysate, and all structures and participant materialsnecessary for the procedure.

12. The combination of claim 5 and wherein said control wall carriespumping means communicating with said recesses, said sheets definingbetween themselves pumping chambers communicating with the latterrecess, said pumping means coacting with the disposable component atsaid pumping chamber thereof for pumping fluid therethrough.

13. The combination of claim 1 and wherein said sheets form portions ofactive controls and pumping mechanisms by interactions such as transferof heat, or pressure relationships between fluid in adjacent layer flowpaths, or via volumetric sizing of the flow paths and reservoirs.

M. For use in the processing of fluids, at least a pair of flexibleplastic sheets sealed to each other according to a predetermined patterndefining between said sheets fluid passages and pockets situatedinwardly of and spaced from the peripheries of said sheets and formingpredetermined flow paths and reservoirs, respectively, for the fluidwhich is to be processed and for containing necessary active principlesof the processing, said sheets having inlet and discharge connectingportions to be connected with fluid supply and discharge lines,respectively, said sheets defining nonparallel intersections of controlpaths with procedural paths functioning as valves by the action ofhigher pressure in the control paths to occlude the flow path lumen.

15. The combination of claim 14 and wherein said sheets have series ofpressure activated intersections to function as pumping mechanism.

16. The combination of claim 13 and wherein said sheets haveproportional resistances within the flow patterns to proportion thevolumes of fluids passing through them.

17. For use in the processing of fluids, at least a pair of flexibleplastic sheets sealed to each other according to a predetermined patterndefining between said sheets fluid passages and pockets situatedinwardly of and spaced from the peripheries of said sheets and formingpredetermined flow paths and reservoirs, respectively, for the fluidwhich is to be processed and for containing necessary active principlesof the processing, said sheets having inlet and discharge connectingportions to be connected with fluid supply and discharge lines,respectively, said sheets defining intersecting control paths withprocedural paths functioning as pressure sensors in procedural path toproportionally alter resistance characteristics of control path circuitsoperating in conjunction with fluidic logic circuits or other pressureor flow sensing mechanisms to react to significant changes in theprocedural flow paths functions.

1. For use in the processing of fluids, at least a pair of flexible plastic sheets sealed to each other according to a predetermined pattern defining between said sheets fluid passages and pockets situated inwardly of and spaced from the peripheries of said sheets and forming predetermined flow paths and reservoirs, respectively, for the fluid which is to be processed and for containing necessary active principles of the processing, said sheets having inlet and discharge connecting portions to be connected with fluid supply and discharge lines, respectively.
 2. The combination of claim 1 and wherein the pattern of sealing of said sheets to each other defines also valve and pumping mechanisms adapted for pumping fluid along said passages and into and out of said reservoirs.
 3. The combination of claim 1 and wherein said sheets are transparent so that fluid between the sheets is visible and can have characteristics thereof detected by light-signal systems.
 4. The combination of claim 1 and wherein said sheets include a mounting portion for adapting the sheets to be mounted on an apparatus which coacts with the sheets.
 5. In an apparatus for processing fluids, a permanent installation and a disposable component to be used therewith, said permanent installation including a control wall having a front surface formed with recesses and grooves according to a predetermined pattern and an access wall with similar recesses and grooves located adjacent said front surface of said control wall for holding a disposable component in engagement with said front surface of said control wall, said disposable component including flexible plastic sheets sealed to each other according to a pattern providing passages and pockets which are situated inwardly of and Spaced from the peripheries of said plastic sheets and which respectively register with said grooves and recesses, said passages and pockets providing predetermined flow paths and reservoirs, respectively, for fluid to be processed, and for containing necessary active principles, and said permanent installation including at said control wall thereof control means communicating with or coacting with said passages and recesses for controlling the flow of fluid in the passages and pockets of the disposable component.
 6. The combination of claim 5 and wherein the control means carried by said control wall includes valve plungers for pressing the sheets of said disposable component together at the passage defined therebetween and for releasing the sheets from each other at the passages so as to close and open, respectively, predetermined fluid passages defined between the sheets.
 7. The combination of claim 5 and wherein said sheets are transparent, and said control means including light-responsive devices responding to the passage of light through said sheets for receiving signals indicative of the characteristics of the fluids, said front wall being transparent so that light can pass through the sheets to provide visibility of the ongoing processes.
 8. The combination of claim 5 and wherein said sheets of said disposable unit include inlet and outlet connections.
 9. The combination of claim 5 and wherein a mounting means forms part of said permanent installation and coacts with said disposable component for mounting the latter removably on the permanent installation.
 10. The combination of claim 5 and wherein said disposable component includes sheets, the area of which is greater than that of said rear wall, said sheets having portions extending beyond said walls of said permanent installation and defining additional pockets and passages for the processed fluid.
 11. The combination of claim 5 and wherein said permanent installation and disposable component form a hemodialysis and analytic monitoring system, said pockets and passages forming a flow path for blood and a flow path for dialysate, and all structures and participant materials necessary for the procedure.
 12. The combination of claim 5 and wherein said control wall carries pumping means communicating with said recesses, said sheets defining between themselves pumping chambers communicating with the latter recess, said pumping means coacting with the disposable component at said pumping chamber thereof for pumping fluid therethrough.
 13. The combination of claim 1 and wherein said sheets form portions of active controls and pumping mechanisms by interactions such as transfer of heat, or pressure relationships between fluid in adjacent layer flow paths, or via volumetric sizing of the flow paths and reservoirs.
 14. For use in the processing of fluids, at least a pair of flexible plastic sheets sealed to each other according to a predetermined pattern defining between said sheets fluid passages and pockets situated inwardly of and spaced from the peripheries of said sheets and forming predetermined flow paths and reservoirs, respectively, for the fluid which is to be processed and for containing necessary active principles of the processing, said sheets having inlet and discharge connecting portions to be connected with fluid supply and discharge lines, respectively, said sheets defining non-parallel intersections of control paths with procedural paths functioning as valves by the action of higher pressure in the control paths to occlude the flow path lumen.
 15. The combination of claim 14 and wherein said sheets have series of pressure activated intersections to function as pumping mechanism.
 16. The combination of claim 13 and wherein said sheets have proportional resistances within the flow patterns to proportion the volumes of fluids passing through them.
 17. For use in the processing of fluids, at least a pair of flexible plastic sheets sealed to each other according to a predeterMined pattern defining between said sheets fluid passages and pockets situated inwardly of and spaced from the peripheries of said sheets and forming predetermined flow paths and reservoirs, respectively, for the fluid which is to be processed and for containing necessary active principles of the processing, said sheets having inlet and discharge connecting portions to be connected with fluid supply and discharge lines, respectively, said sheets defining intersecting control paths with procedural paths functioning as pressure sensors in procedural path to proportionally alter resistance characteristics of control path circuits operating in conjunction with fluidic logic circuits or other pressure or flow sensing mechanisms to react to significant changes in the procedural flow paths functions. 